UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060894 |
|---|---|
| Receipt number | R000069581 |
| Scientific Title | Changes in Skin Findings Following the Use of Booster Serum and Serum Alone or in Combination: An Exploratory Randomized Parallel-Group Interventional Study Using VISIA, Dermoscopy, and Questionnaire Assessments |
| Date of disclosure of the study information | 2026/03/11 |
| Last modified on | 2026/03/11 11:47:06 |
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Basic information
Public title
A study on changes in skin condition with the use of booster serum and serum alone or in combination
Acronym
Skin Change Study with Booster and Serum
Scientific Title
Changes in Skin Findings Following the Use of Booster Serum and Serum Alone or in Combination: An Exploratory Randomized Parallel-Group Interventional Study Using VISIA, Dermoscopy, and Questionnaire Assessments
Scientific Title:Acronym
Booster and Serum Skin Evaluation RCT
Region
| Japan |
Condition
Condition
Not applicable (Healthy adults)
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate changes in skin condition in healthy adult men and women following the use of an introductory serum and a cosmetic serum, either alone or in combination, using VISIA image analysis, dermoscopy, and questionnaire assessments. This study will obtain preliminary data to inform the design of future comparative trials (including intervention duration, required sample size, and selection of appropriate outcome measures), and will establish objective scientific evidence of product characteristics to support appropriate information provision.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to Day 28 in facial skin parameters (wrinkles, pores, pigmentation, redness, and skin texture) assessed by VISIA image analysis
Key secondary outcomes
Change from baseline to Day 28 in dermoscopic skin microstructure findings
Change from baseline to Day 28 in subject-reported skin condition scores assessed by questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will apply the booster serum twice daily (morning and evening) to the entire face after cleansing. After application, they will perform their usual skincare routine. The intervention period will be 28 days. Initiation of new skincare products during the study period will be prohibited.
Interventions/Control_2
Participants will apply the serum twice daily (morning and evening) to the entire face after cleansing and application of lotion (toner). After application, they will perform their usual skincare routine. The intervention period will be 28 days. Initiation of new skincare products during the study period will be prohibited.
Interventions/Control_3
After cleansing, participants will apply an appropriate amount of the booster serum to the entire face. Subsequently, after applying lotion (toner), they will apply an appropriate amount of the serum to the entire face and then proceed with their usual skincare routine. This procedure will be performed twice daily (morning and evening). The intervention period will be 28 days. Initiation of new skincare products during the study period will be prohibited.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To explore changes in skin condition following cosmetic use in healthy adult males and females.
Key exclusion criteria
Individuals with a known history of allergy to any ingredients of the investigational products.
Individuals with severe skin diseases (e.g., severe facial eczema, active skin infections).
Pregnant or breastfeeding women, or those highly likely to be pregnant (according to institutional policy).
Individuals planning to undergo medical or cosmetic facial procedures (e.g., laser treatment, chemical peeling, injections) during the study period.
Individuals judged inappropriate for participation by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kishio |
| Middle name | |
| Last name | Kuroda |
Organization
0th CLINIC
Division name
Medical Director
Zip code
103-0027
Address
CAMCO Nihonbashi Building 4F, 2-16-9 Nihonbashi, Chuo-ku Tokyo
TEL
03-6281-9280
k.kuroda@0thclinic.com
Public contact
Name of contact person
| 1st name | Mitsuki |
| Middle name | |
| Last name | Irie |
Organization
Rainmakers Co., Ltd.
Division name
New Business Development Department
Zip code
103-0027
Address
L.Biz Nihonbashi 4F, 2-9-10 Nihonbashi, Chuo-ku Tokyo
TEL
080-4191-0684
Homepage URL
m.irie@rainmakers.jp
Sponsor or person
Institute
Rainmakers Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Rainmakers Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic, Medical Corporation Ouryokukai
Address
Inamura Building 5F, 1-9-2 Nihonbashi Kayabacho, Chuo-ku Tokyo
Tel
03-6661-9061
c-irb_ug@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069581
